FDA recall Z-1132-2023

Product

EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve) Model/Serial: CF-Q180AL

Reason for recall

A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in error, potential for microbial contamination

Distribution

US Nationwide distribution in the states of CA, FL, GA, NY, OR, VA.

Key facts

Status

Ongoing

Initiation date

2022-12-21

Report date

2023-02-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1132-2023